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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Intas Pharmaceuticals

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    01 Apremilast (1)

    02 Azacitidine (2)

    03 Bendamustine Hydrochloride (1)

    04 Cabazitaxel (1)

    05 Capecitabine (2)

    06 Carfilzomib (1)

    07 Carmustine (1)

    08 Dabigatran Etexilate Mesylate (1)

    09 Dasatinib (1)

    10 Decitabine (1)

    11 Dimethyl Fumarate (1)

    12 Diroximel fumarate (1)

    13 Docetaxel (5)

    14 Dofetilide (1)

    15 Doxorubicin Hydrochloride (1)

    16 Epirubicin Hydrochloride (1)

    17 Erlotinib Hydrochloride (1)

    18 Fampridine (1)

    19 Fesoterodine (1)

    20 Fingolimod Hydrochloride (1)

    21 Gemcitabine (2)

    22 Imatinib Mesylate (1)

    23 Lacosamide (1)

    24 Lurasidone Hydrochloride (1)

    25 Paclitaxel (3)

    26 Pazopanib Hydrochloride (1)

    27 Perampanel (1)

    28 Prasugrel Hydrochloride (1)

    29 Pregabalin (2)

    30 Ribociclib (1)

    31 Rivaroxaban (1)

    32 Sodium Methoxide Solution (1)

    33 Sodium Thiosulfate (1)

    34 Teriflunomide (1)

    35 Tipiracil Hydrochloride (1)

    36 Tofacitinib Citrate (1)

    37 Trazodone Hydrochloride (1)

    38 Trifluridine (1)

    39 Vilazodone Hydrochloride (1)

    filter

    01 Active (38)

    02 Inactive (7)

    03 Blank (4)

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    01 Valid (17)

    02 Withdrawn by Holder (1)

    03 Blank (31)

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    01 Blank (49)

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    01 WC-0357 (2)

    02 WC-0440 (2)

    03 WC-0440A1 (1)

    04 WC-0440A2 (1)

    05 Blank (43)

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    Pregabalin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    27839
    Active
    PREGABALIN
    2014-01-06
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-028 - Rev 00
    Valid
    Pregabalin, Process II
    2023-07-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0440
    Valid
    Pregabalin IH
    2022-02-02
    Application Number
    27839
    R0-CEP 2022-028 - Rev 00
    Indian CDSCO WC-0440
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-03-04
    Filing Details
    PREGABALIN
    Pregabalin, Process II
    Pregabalin IH
    Issue/Submission Date
    2014-01-06
    2023-07-04
    2022-02-02
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    Doxorubicin Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34545
    Active
    DOXORUBICIN HYDROCHLORIDE USP
    2020-01-27
    CEP/COS

    Found CEP/COS

    CEP 2012-367 - Rev 02
    Valid
    Doxorubicin Hydrochloride
    2024-03-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0357
    Expired
    Doxorubicin Hydrochloride BP/EP
    2020-06-23
    Application Number
    34545
    CEP 2012-367 - Rev 02
    Indian CDSCO WC-0357
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2023-10-05
    Filing Details
    DOXORUBICIN HYDROCHLORIDE USP
    Doxorubicin Hydrochloride
    Doxorubicin Hydrochloride BP/EP
    Issue/Submission Date
    2020-01-27
    2024-03-20
    2020-06-23
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    Rivaroxaban

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    USDMF

    Found USDMF

    30562
    Active
    RIVAROXABAN FORM- I (MICRONIZED)
    2016-06-08
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-178 - Rev 00
    Valid
    Rivaroxaban, Micronised
    2022-09-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0440A2
    Expired
    Rivaroxaban IH
    2022-01-05
    Application Number
    30562
    R0-CEP 2020-178 - Rev 00
    Indian CDSCO WC-0440A2
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-03-04
    Filing Details
    RIVAROXABAN FORM- I (MICRONIZED)
    Rivaroxaban, Micronised
    Rivaroxaban IH
    Issue/Submission Date
    2016-06-08
    2022-09-06
    2022-01-05
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    Azacitidine

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    USDMF

    Found USDMF

    27821
    Active
    AZACITIDINE
    2013-12-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0440
    Valid
    Azacitidine IH
    2022-02-02
    Application Number
    27821
    Indian CDSCO WC-0440
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-03-04
    Filing Details
    AZACITIDINE
    Azacitidine IH
    Issue/Submission Date
    2013-12-30
    2022-02-02
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    Capecitabine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24370
    Active
    CAPECITABINE USP
    2010-11-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-325 - Rev 01
    Valid
    Capecitabine
    2022-06-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24370
    R1-CEP 2015-325 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CAPECITABINE USP
    Capecitabine
    Issue/Submission Date
    2010-11-09
    2022-06-24
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    Capecitabine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33574
    Active
    CAPECITABINE USP (PROCESS II)
    2019-03-04
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-143 - Rev 01
    Valid
    Capecitabine, Process II
    2022-06-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33574
    R0-CEP 2019-143 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CAPECITABINE USP (PROCESS II)
    Capecitabine, Process II
    Issue/Submission Date
    2019-03-04
    2022-06-27
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    Carmustine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33730
    Active
    CARMUSTINE USP
    2019-03-26
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-272 - Rev 01
    Valid
    Carmustine
    2022-06-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33730
    R0-CEP 2019-272 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CARMUSTINE USP
    Carmustine
    Issue/Submission Date
    2019-03-26
    2022-06-27
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    Docetaxel

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28756
    Active
    DOCETAXEL ANHYDROUS USP (PROCESS II...
    2014-10-29
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-155 - Rev 00
    Valid
    Docetaxel, Process-IIb
    2020-09-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28756
    R0-CEP 2020-155 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DOCETAXEL ANHYDROUS USP (PROCESS II...
    Docetaxel, Process-IIb
    Issue/Submission Date
    2014-10-29
    2020-09-18
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    Fingolimod Hydrochloride

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    USDMF

    Found USDMF

    28387
    Active
    FINGOLIMOD HYDROCHLORIDE (FORM 1)
    2014-06-24
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-090 - Rev 01
    Valid
    Fingolimod hydrochloride
    2023-07-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28387
    R0-CEP 2020-090 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FINGOLIMOD HYDROCHLORIDE (FORM 1)
    Fingolimod hydrochloride
    Issue/Submission Date
    2014-06-24
    2023-07-05
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    Gemcitabine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22748
    Active
    GEMCITABINE HYDROCHLORIDE USP
    2009-04-15
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-092 - Rev 00
    Valid
    Gemcitabine hydrochloride, Process ...
    2022-07-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22748
    R0-CEP 2022-092 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    GEMCITABINE HYDROCHLORIDE USP
    Gemcitabine hydrochloride, Process ...
    Issue/Submission Date
    2009-04-15
    2022-07-13
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